An Animation- Versus Text-based Computer-tailored Game Intervention to Prevent Alcohol Consumption in Adolescents

October 9, 2022 updated by: Marta Lima Serrano, University of Seville

ALERTA ALCOHOL: The Development and Evaluation of an Animation- Versus Text-based Computer-tailored Game Intervention to Prevent Alcohol Consumption and Binge Drinking in Adolescents

This study consists in the design, implementation and evaluation of an animation (Alerta Alcohol 2.0)- versus text-based (Alerta Alcohol) computer-tailored game intervention aimed to prevent alcohol consumption and binge drinking (BD) in Spanish adolescents. A Cluster Randomized Controlled Trial (CRCT) is conducted to test the effectiveness of Alerta Alcohol versus Alerta Alcohol 2.0 in students aged 14 to 19 years across 24 high schools from Andalusia (southern Spain), which are randomized either to the experimental (EC-1, EC-2) or the control conditions (CC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Alcohol use and misuse, and particularly, BD in adolescents are a highly prevalent healthcare problem that associates physical and mental health complications and community implications. The Alerta Alcohol and Alerta Alcohol 2.0 programs are based on the I-Change Model. A CRCT is carried out. The schools from Andalusia are randomized either to the experimental (EC-1, EC-2) or the control conditions (CC). The EC-1 receives an online intervention (Alerta Alcohol, which has adapted from a previous version) with personalized health advice, using textual feedback and several gamification techniques, and consists of nine sessions (performing seven of them at the high school): session 1 or baseline, sessions 2 and 3 where adolescents are provided with answers related to their views to provide highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence and self-efficacy; sessions 4, 5, 7 and 8 are reinforcement sessions (booster sessions) and sessions 6 and 9 are follow-up questionnaires at six and twelve months. The EC-2 receives an improved version of Alerta Alcohol (Alerta Alcohol 2.0) using animated videos and new gamification strategies. The CC just completes the baseline and the evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list). To test the effectiveness, the primary outcome is BD within 30 days prior to evaluation and alcohol use (high-intensity drinking, weekly and any consumption) in the previous week as secondary outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2625

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain, 41009
        • Marta Lima Serrano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Students aged 14 to 19 years.
  • Enrolled in Andalusian public or private high schools.
  • Access to the Internet at the schools and the use of computer, mobile or tablet is allowed.
  • Access to the Internet in their homes.

Exclusion Criteria:

  • Language barriers.
  • Previous participation in prevention programs for BD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Alerta Alcohol
The EC-1 receives Alerta Alcohol, which consists of session 1 or baseline, two sessions in three scenarios: at home, celebrations, and public places, and two follow-up evaluations. The adolescents are provided with answers related to their views of each scenario; this information is used to provide highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence (modelling, norms and social pressure), self-efficacy and action plans. In addition, four booster sessions are given at home to reinforce the contents of the three scenarios. Evaluations take place after six and twelve months.
Behavioral: Alerta Alcohol
The intervention consists of preventive messages about the benefits of not consuming alcohol, reducing the positive attitudes and encouraging the negative attitudes towards alcohol drinking and BD, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject BD. This information is presented through different tailored text messages. Moreover, several gamification strategies are used (i.e. offering a challenge, giving different stories and the use of avatars in these stories that take place in three different scenarios: at home, at celebrations and in public places).
Other Names:
  • A text-based computer-tailored game intervention
Experimental: Alerta Alcohol 2.0
The EC-2 receives an improved version of Alerta Alcohol (Alerta Alcohol 2.0) using animated videos and new gamification strategies. Evaluations take place after six and twelve months.
Behavioral: Alerta Alcohol 2.0
The intervention consists of preventive messages about the benefits of not consuming alcohol, reducing the positive attitudes and encouraging the negative attitudes towards alcohol drinking and BD, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject BD. This information is presented through different animated videos. Moreover, new gamification strategies are added (i.e. giving rewards and allocating points that can be accumulated and shown in a progress ranking) to those already used in Alerta Alcohol.
Other Names:
  • An animation-based computer-tailored game intervention
No Intervention: Control condition
The CC just completes the baseline and the evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list). Evaluations take place after six and twelve months from baseline.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change on the prevalence of binge drinking
Time Frame: 6 months after the baseline
Change on the prevalence of binge drinking (4/5 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within 30 days prior to evaluation.
6 months after the baseline
Change on the prevalence of binge drinking
Time Frame: 12 months after the baseline
Change on the prevalence of binge drinking (4/5 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within 30 days prior to evaluation.
12 months after the baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change on the prevalence of high-intensity drinking
Time Frame: 6 months after the baseline
Change on the prevalence of high-intensity drinking (8/10 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within the 7 days prior to evaluation.
6 months after the baseline
Change on the prevalence of high-intensity drinking
Time Frame: 12 months after the baseline
Change on the prevalence of high-intensity drinking (8/10 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within the 7 days prior to evaluation.
12 months after the baseline
Change on the average of weekly consumption
Time Frame: 6 months after the baseline
Change on the average of the total number of glasses consumed within the 7 days prior to evaluation.
6 months after the baseline
Change on the average of weekly consumption
Time Frame: 12 months after the baseline
Change on the average of the total number of glasses consumed within the 7 days prior to evaluation.
12 months after the baseline
Change on the prevalence of any consumption
Time Frame: 6 months after the baseline
Change on the prevalence of any consumption
6 months after the baseline
Change on the prevalence of any consumption
Time Frame: 12 months after the baseline
Change on the prevalence of any consumption
12 months after the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Seville

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maastricht University
Delegación del Gobierno para el Plan Nacional sobre Drogas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • University of Seville (Spain)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The IPD will be shared with other researchers through publications in scientific journals and conferences/congresses.

IPD Sharing Time Frame

From 2021.

IPD Sharing Access Criteria

The Access Criteria will be the one exposed by the scientific journals where the results of the study will be published.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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